an bioequivalence study of loxoprofen sodium patches in healthy volunteers

Conditions: Osteoarthritis; Muscle Pain; Swelling Muscle

Summary: this study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.

the objectives of this study are to evaluate the difference of absorption degree and absorption rate of two kinds of patches( fb3002 vs. loxonin®) in chinese healthy population, and to assess the bioavailability of these two patches.

Eligibility criteria:
inclusion criteria: * male weight ≥50 kg, female weight ≥45 kg, body mass index (bmi) between 19.0 and 28.0 kg/m2, inclusive . * informed consent: signed written informed consent before inclusion in the study. * the subjects are well communicated and are able to comply with the requirements of the study exclusion criteria: * participated in other drug intervention studies within 90 days * allergic to this product and excipients, or have a history of food, drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.) * aspirin asthma * any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial. * a history of cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, immune system, nervous/psychiatric system, blood and lymphatic system, and skeletal musculoskeletal system that investigator have determined to be abnormal and clinically significant * postural hypotension, needle fainting or blood fainting history or venipuncture intolerance * any drug that inhibits or induces liver metabolism has been used in the 30 days prior to screening. inducers: barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole; inhibitors: ssri antidepressants, cimetidine, diltiazem, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines * blood donation or significant blood loss (\>400 ml, except for female menstrual period) in the 3 months prior to screening, blood transfusion or use of blood products, or have a blood donation plan during/within 3 months after the study * smoked more than 5 cigarettes per day in the 3 months prior to screening, or unwilling to prohibit the use of any tobacco products during the trial period * history of alcohol abuse within 6 months * subjects who consumed excessive amounts of tea, coffee or caffeinated beverages within 3 months, or who did not agree to the prohibition of tea, coffee or caffeinated beverages in the study * subjects who have special requirements for diet and cannot comply with a unified diet * history of drug abuse within 1 year * subjects who have unprotected sex in 2 weeks, or planned to have a child during the study period, planned to donate sperm and eggs, or are unwilling to use one or more non-drug contraceptive methods during the study, or are unwilling to use contraception within 3 months after the study * pregnant or nursing women * positive skin scratch test positive * clinically significant vital signs laboratory, physical examination, or 12-lead electrocardiogram abnormalities as judged by the investigator * other situations that the investigator determines are not suitable for participating in this clinical trial